Elutia Awarded Cardiac Rhythm Management Devices Agreement With Premier, Inc.
Elutia Awarded Cardiac Rhythm Management Devices Agreement With Premier, Inc.
SILVER SPRING, Md., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) ("Elutia" or the "Company"), a pioneer in drug-eluting biomatrix products, announced it has been awarded a national group purchasing agreement for Cardiac Rhythm Management Devices with Premier, Inc. Effective November 15, 2024, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for the EluPro Antibiotic-Eluting BioEnvelope.
马里兰州银泉,2024年12月02日(环球新闻社)-Elutia公司(纳斯达克:ELUT)(“Elutia”或“公司”)是药物缓释生物基体产品的先驱,宣布已获得与Premier公司签订的心脏节律管理设备的全国集团采购协议。自2024年11月15日起,新协议允许Premier成员自行决定是否利用Premier为EluPro抗生素缓释生物封套预先协商的特别定价和条款。
"We are thrilled to bring EluPro to a broader audience through this new agreement with Premier," said Dr. Randy Mills, Elutia's Chief Executive Officer. "EluPro reflects Elutia's dedication to providing electrophysiologists and their patients with cutting-edge solutions that address the leading causes of post-surgical complications in pacemaker and defibrillator implants and improve quality of life. This agreement underscores our shared vision of advancing healthcare through innovation and collaboration."
“通过与Premier的新协议,我们很高兴将EluPro推广到更广泛的受众群体,”Elutia首席执行官兰迪·米尔斯博士说。“EluPro体现了Elutia致力于为心电生理学家及其患者提供最尖端解决方案的承诺,解决心脏起搏器和除颤器植入术后并发症的主要原因,并提高生活质量。该协议强调了我们通过创新和合作共同推动医疗保健领域发展的共同愿景。”
EluPro, the world's first and only antibiotic-eluting biologic envelope cleared by the U.S. Food and Drug Administration, represents a breakthrough for cardiac rhythm management. Through advanced tissue engineering, EluPro integrates clinically proven antibiotics with natural extracellular matrix (ECM) to create a soft, conforming bioenvelope that provides optimal stability for implantable electronic devices. It delivers powerful antibiotics directly to the surgical site, extending protection well beyond closure. Over time, EluPro remodels into a healthy, vascularized pocket of the patient's own tissue, reducing inflammation, scar formation, and foreign body response, which promotes better healing and simplifies potential device upgrades. By setting a new standard in device protection, EluPro redefines patient outcomes and procedural success.
EluPro是美国食品和药物管理局批准的世界上第一个也是唯一的抗生素缓释生物封套,为心脏节律管理开辟了一条新路。通过先进的组织工程技术,EluPro将临床证实的抗生素与天然细胞外基质(ECM)结合,创建出软性、符合性的生物封套,为植入式电子设备提供最佳稳定性。它可直接向手术部位释放强效抗生素,使保护效果远超封闭位置。随着时间的推移,EluPro变成患者自身组织的健康、有血管化的囊袋,减少炎症、疤痕形成和对异物的反应,促进更好的愈合,简化可能的设备升级。EluPro在设备保护方面设立了新标准,重新定义了患者预后和手术成功。
Premier is a leading technology-driven healthcare improvement company, providing solutions to two-thirds of all healthcare providers in the U.S. Playing a critical role in the rapidly evolving healthcare industry, Premier unites providers, suppliers, payers and policymakers to make healthcare better with national scale, smarter with actionable intelligence and faster with novel technologies. With integrated data and analytics, collaboratives, supply chain solutions, consulting and other services, Premier enables better care and outcomes at a lower cost.
Premier是一家领先的技术驱动型医疗保健改进公司,为美国三分之二的医疗保健提供者提供解决方案。在快速发展的医疗保健行业中发挥关键作用,Premier将提供者、供应商、付款方和政策制定者汇集在一起,通过国家规模使医疗保健变得更好,利用可操作的智能信息使医疗保健更智能,并借助新颖技术使医疗保健更快速。通过整合数据和分析、协作、供应链解决方案、咨询和其他服务,Premier实现了更好的护理和更低成本的结果。
About Elutia
关于Elutia
Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia's mission is humanizing medicine so patients can thrive without compromise. For more information, visit .
Elutia开发并商业化药物洗脱生物矩阵产品,以提高医疗设备和需要它们的患者之间的兼容性。随着需要植入技术的人口不断增长,Elutia的使命是使医学更加人性化,以便患者可以在不妥协的情况下茁壮成长。欲了解更多信息,请访问 .
Forward Looking Statements
前瞻性声明
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential," "promise" or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information concerning the launch of EluPro, including the timing and anticipated success thereof. These forward-looking statements are based on our management's beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to successfully commercialize, market and sell our newly approved EluPro product; our ability to continue as a going concern; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the November 2023 sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; and our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the "Risk Factors" section of Elutia's public filings with the Securities and Exchange Commission ("SEC"), including Elutia's Annual Report on Form 10-K for the year ended December 31, 2023, as such factors may be updated from time to time in Elutia's other filings with the SEC, including Elutia's Quarterly Reports on Form 10-Q, accessible on the SEC's website at www.sec.gov and the Investor Relations page of Elutia's website at Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
本新闻稿包含《证券法》修订的第27A条和1934年修订的《证券交易法》第21E条中“前瞻性声明”的含义。可通过诸如“项目”、“可能”、“将”、“可能”、“应该”、“相信”、“预期”、“预期”、“估计”、“打算”、“计划”、“潜力”、“承诺”或类似表示对未来时期的引用来识别前瞻性声明。本新闻稿中包含的所有与历史事实无关的声明都应被视为前瞻性声明,包括任何涉及EluPro上市以及其预计成功的时间和预期成功的所有声明和信息。这些前瞻性声明基于我们管理层的信念和假设以及目前对我们可得到的信息。这些信念和假设可能被证明正确或不正确。此外,此类前瞻性声明受到多个已知和未知风险、不确定性和其他重要因素的影响,这可能导致我们的实际结果、业绩或成就与前瞻性声明中明示或暗示的任何未来结果、业绩或成就大不相同,包括但不限于以下方面:我们成功商业化、推广和卖出新获批准的EluPro产品的能力;我们能否继续作为持续营业的公司;我们能否实现或维持盈利能力;产品责任索赔风险以及我们能否获得或维持充足的产品责任保险;我们能否抵抗与召回的FiberCel和其他可行骨基质产品相关的各种诉讼和索赔,避免因这些诉讼和索赔导致重大不利的财务影响;医疗界对我们产品的持续和未来接受程度;我们开发新产品、扩大产品适应症范围和开发、收购和商业化额外产品方面的能力;我们对商业合作伙伴和独立销售代理商的依赖,后者为实现我们净销售额的大部分贡献;我们对数量有限的第三方供应商和制造商的依赖,在某些情况下,这些供应商是我们业务所必需的产品的独家供应商;我们能否成功实现2023年11月出售我们Orthobiologics业务的预期收益;医生对我们产品的独特特性、优势、安全性、临床效力和成本效益的认识;我们所处的其他公司竞争环境,其中大部分公司具有更长的运营历史、更成熟的产品和/或更丰富的资源;由于我们的客户、采购团体、第三方支付方和政府机构的成本控制努力而带来的价格压力可能对我们的销售和盈利能力产生不利影响;我们能否获得FDA和类似外国管理机构对我们产品和产品候选药物的审批或其他市场授权;以及我们能否获得、维持和充分保护我们的知识产权;在Elutia向证券交易委员会(“SEC”)的公开备案中可找到其他重要因素,包括Elutia截至2023年12月31日的年度报告第10-K中的“风险因素”部分,这些因素可能会随时间更新在Elutia的其他向SEC备案的文件中,包括Elutia的第10-Q季度报告,可在SEC网站 www.sec.gov和Elutia网站的投资者关系页面查阅。由于前瞻性声明本质上受到风险和不确定性的影响,您不应将这些前瞻性声明作为未来事件的预测。Elutia在本新闻稿中所做的任何前瞻性声明仅基于目前可获得的信息,并仅于其作出的日期发表时有效。除适用法律要求外,Elutia明确否认有义务公开更新任何前瞻性声明,无论是书面还是口头的,这些前瞻性声明可能随时在新信息、未来发展或其他情况下作出。
Investors:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com
投资者:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com